ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12610000544077

Ethics application status

Approved

Date submitted

5/07/2010

Date registered

6/07/2010

Date last updated

7/02/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

A randomised controlled trial of pneumococcal conjugate vaccines Synflorix and Prevenar13 in sequence or alone in high-risk Indigenous infants (PREV-IX): immunogenicity, carriage and otitis media outcomes

Scientific title

In high-risk Indigenous infants does an early combination schedule of two pneumococcal conjugate vaccines Synflorix and Prevenar13 provide greater pathogen protection than standard single vaccine schedules.

Secondary ID [1]

National Health and Medical Research Council (NHMRC) project grant 605810.

Universal Trial Number (UTN)

Trial acronym

PREVIX_COMBO

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Otitis media in Indigenous infants

Pneumococcal disease

Non-typeable Haemophilus influenzae disease

Condition category

Condition code

Ear

Other ear disorders

Infection

Studies of infection and infectious agents

Public Health

Epidemiology

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1. Vaccination with Synflorix (intramuscular injection 0.5ml) at 1,2,4 months of age and Prevenar13 at 6 months of age. Final follow up at 7 months of age.

Intervention code [1]

Prevention

Comparator / control treatment

1. Vaccination with Prevenar13 (intramuscular injection 0.5ml) at 2,4 and 6 months of age.
2. Vaccination with Synflorix (intramuscular injection 0.5ml)at 2,4 and 6 months of age.
Final follow up at 7 months of age.

Control group

Active

Outcomes

Primary outcome [1]

Proportion of infants with serum pneumococcal Immunoglobulin G (IgG) geometric mean concentration (GMC) above threshold (0.35 microg/ml). Determined by Enzyme Linked Immunosorbent Assay.

Timepoint [1]

7 months of age

Primary outcome [2]

Serum pneumococcal IgG geometric mean concentration (GMC). Determined by Enzyme Linked Immunosorbent Assay.

Timepoint [2]

7 months of age

Secondary outcome [1]

Proportion of children with carriage of serotype 19A pneumococci. Determined by nasal swab and standard microbiological culture for pneumococci. Serotype determined by Quellung reaction.

Timepoint [1]

7 months of age

Secondary outcome [2]

Proportion of children with carriage of Haemophilus influenzae (H. influenzae). Determined by nasal swab and standard microbiological culture for H. influenzae.

Timepoint [2]

7 months of age

Secondary outcome [3]

Proportion of children with any otitis media determined by otoscopy and tympanometry.

Timepoint [3]

7 months of age

Eligibility

Key inclusion criteria

Indigenous infants less than 6 weeks of age, living in a remote community and eligible for pneumococcal vaccination.

Minimum age

4 Weeks

Maximum age

6 Weeks

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

less than 32 weeks gestation

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Subjects will be sought through antenatal clinics. Staff will ask pregnant women if they are interested in being contacted by Menzies School of Health Research about participating in ear health research. Research staff will contact interested women late in their pregancy for informed consent (Phase I) and again before their baby is 4 weeks of age (Phase II). Consented babies will be allocated to one of the three groups by the National Health and Medical Research Council Clinical Trials Centre, using their phone randomisation service. Allocation concealment will be achieved using this central randomisation by phone.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Sequence generation will be computer generated random number series.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Block randomisation will be used to maintain equal numbers in the 3 groups. We will stratify by place of residence (community).

Phase

Phase 3 / Phase 4

Type of endpoint/s

Bio-equivalence

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

29/08/2011

Actual

28/09/2011

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

425

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NT,WA

Recruitment postcode(s) [1]

0800

Recruitment postcode(s) [2]

6743 - Kununurra

Recruitment postcode(s) [3]

0822 - Bathurst Island

Recruitment postcode(s) [4]

0822 - Wadeye

Recruitment postcode(s) [5]

0822 - Maningrida

Recruitment postcode(s) [6]

0870 - Alice Springs

Recruitment postcode(s) [7]

6430 - Kalgoorlie

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Menzies School of Health Research

Address

PO Box 41096
Casuarina
Northern Territory 0811

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Amanda Leach

Address [1]

Menzies School of Health Research
PO Box 41096
Casuarina
Northern Territory 0811

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee of Northern Territory (NT) Department of Health and Families and Menzies School of Health Research

Ethics committee address [1]

Menzies School of Health Research
PO Box 41096
Casuarina
Northern Territory 0811

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/06/2010

Approval date [1]

25/06/2010

Ethics approval number [1]

10/1395

Summary

Brief summary

The bacterium pneumococcus causes invasive disease, pneumonia and otitis media in young children.  Seven-valent pneumococcal conjugate vaccine (PCV7) has been provided for Aboriginal and high risk children since 2001 and all Australian children since 2005.  There are two new pneumococcal conjugate vaccines to be licensed in Australia by the end of 2010.  These have 10 pneumococcal serotypes in common but one also offers protection from H. influenzae infection and the other has 3 additional pneumococcal serotypes.  H. influenzae causes otitis media and non-bacteraemic pneumonia but is rarely cultured from blood cultures and thus is considered a less invasive pathogen. For Aboriginal children however, H. influenzae is the major pathogen associated with perforated tympanic membranes (ear drums) and it is thought to be an important cause of pneumonia.  Invasive disease caused by the additional serotypes, particularly 19A, has increased in Australian non-indigenous population.  Thus it is anticipated that most jurisdictions will choose to use the PCV13. However, because Indigenous children have much higher rates of infection due to H. influenzae than non-Indigenous children, Indigenous children may benefit from both vaccines. There are no studies that directly compare these two vaccines to determine overall clinical benefit.  This  Randomised Controlled Trial (RCT) will directly compare the two vaccines as well as an early 3+1 combination schedule, commencing at one months of age.  Immunological, microbiological and clinical outcomes will be assessed.

Trial website

none

Trial related presentations / publications

Internationl Symposium on Pneumococci and Pneumococcal Diseases, ISPPD7. Tel Aviv March 2010.
Pneumococcal Conjugate Vaccines SynflorIX (PHiD-CV) & PREVenar (13PCV) in combination: PREV-IX_COMBO: A RCT of a mixed early schedule for high-risk infants.

Public notes

Contacts

Principal investigator

Name

Prof Amanda Leach

Address

Menzies School of Health Research PO Box 41096 Casuarina 0811 Northern Territory

Country

Australia

Phone

+61 8 89228649

Fax

Amanda.leach@menzies.edu.au

Contact person for public queries

Name

Amanda Leach

Address

Menzies School of Health Research
PO Box 41096
Casuarina 0811
Northern Territory

Country

Australia

Phone

+61 8 89228196

Fax

+61 8 89275187

amanda.leach@menzies.edu.au

Contact person for scientific queries

Name

Amanda Leach

Address

Menzies School of Health Research
PO Box 41096
Casuarina 0811
Northern Territory

Country

Australia

Phone

+61 8 89228196

Fax

+61 8 89275187

amanda.leach@menzies.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	Citations or Other Details
4282	Study results article	Yes	Beissbarth, J., Wilson, N., Arrowsmith, B., Binks,... [More Details]
4283	Study results article	Yes	Leach, A. J., Mulholland, E. K., Santosham, M., To... [More Details]
4284	Study results article	Yes	Leach, A. J., Wilson, N., Arrowsmith, B., Beissbar... [More Details]
4285	Study results article	Yes	Leach, A. J., Wilson, N., Arrowsmith, B., Beissbar... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Pneumococcal conjugate vaccines PREVenar13 and SynflorIX in sequence or alone in high-risk Indigenous infants (PREV-IX_COMBO): protocol of a randomised controlled trial	2015	https://doi.org/10.1136/bmjopen-2014-007247
Embase	Nasopharyngeal carriage of otitis media pathogens in infants receiving 10-valent non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10), 13-valent pneumococcal conjugate vaccine (PCV13) or a mixed primary schedule of both vaccines: A randomised controlled trial.	2021	https://dx.doi.org/10.1016/j.vaccine.2021.03.032
Embase	Otitis media outcomes of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine and 13-valent pneumococcal conjugate vaccine schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial.	2021	https://dx.doi.org/10.1186/s12887-021-02552-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically